No Prescription? No Problem

Wincing in agony, Barbara Stouffer* tried to tune out the echoing voices of her four kids. Her head throbbed with such piercing pain that the 38-year-old New Jersey mother could barely get out of bed--much less pay attention to her children. Earlier that day, the headache pressure was so excruciating that she had crawled on hands and knees to the bathroom to throw up.

Wearily, she reached for the crumpled white envelope near her bedside. Painkillers, white pills flecked with blue, from an overseas Web site rolled loose inside. She knew she was taking her chances with a drug she had bought without a prescription, but her migraine was unbearable. She popped two of the pills in her mouth, swallowed hard, and felt a slight burning sensation in her stomach. Twenty minutes later, relief finally came.

For Stouffer and millions of other online pharmacy users, the Internet offers swift salvation. A computer and a credit card provide unlimited access to cheap drugs, potent painkillers, and hope-in-a-bottle experimental medications. Internet shoppers have privacy and, in many cases, can skip expensive and sometimes embarrassing visits to a doctor.

In 2004, consumers will spend an estimated $15 billion on Web-bought drugs, predicts the Internet data firm Forrester Research. Many will order from legitimate online businesses--including major US drugstore chains such as CVS and Eckerd, as well as some Canadian suppliers--that require a faxed or mailed prescription from a licensed doctor who's done a face-to-face physical exam. Other customers, lured by relentless spam, low prices, and easy access, will visit sites where the only requirement for delivery is a credit card. No prescription? No problem.In a 4-month investigation, Prevention probed the shadowy world of rogue Internet pharmacies to examine the way this new phenomenon is unfolding and to better understand how consumers are using the Web to get prescription drugs. To determine whether buying drugs online is a safe and reliable option, we reviewed government and court records, visited scores of e-pharmacy Web sites, and analyzed drug prices for comparisons. We interviewed dozens of authorities, including FDA officials, counterfeiting experts, pharmacists, doctors, law enforcement officials, e-pharmacy employees, and online consumers. Without prescriptions--and sometimes by listing false symptoms on the sites' medical questionnaires--Preventionsources ordered a wide variety of drugs. Each medication was advertised as the genuine product, but because the investigation included apparent foreign and unregulated sites, there was no way our sources could know what they were getting, where it was sent from--or whether it would come at all. Some drugs arrived in vials and boxes bearing the logos of manufacturers; others arrived in unlabeled plastic bags and envelopes.

*Names changed to protect the privacy of the individuals who agreed to be interviewed[pagebreak]

Investigation Reveals Risks

Since the e-pharmacies that sent these drugs didn't require a prescription from a face-to-face doctor visit, our sources were able to order drugs a qualified physician would never have prescribed, given the age, gender, or medical conditions they listed on the online forms. The medications were mailed from US distributors as well as suppliers in England, Mexico, Spain, Fiji, and Thailand. (Preventionis sharing the results of this investigation with the FDA and pharmaceutical and medical boards.)

Next, Preventiontested five different orders of what was advertised as the anti-impotence drug Viagra to see if the pills we received contained the active ingredient, sildenafil citrate. (Viagra, used to enhance sex, is a popular Web seller with men, women, and teens, and is often counterfeited.)

Our conclusion: The right to buy cheap drugs privately can come at a high cost. By diagnosing themselves, consumers risk drug interactions, incorrect dosing, allergic reactions, and worse. Purchasing drugs from illegal sites puts buyers in danger of getting fake, mislabeled, or expired medications--and of not receiving their order at all. Here's what else we discovered:

It's astonishingly easy to get medications. With the same effort it takes to order a best-seller from Amazon.com, you can get almost any drug you want--legally or illegally--from Viagra to the potent painkiller hydrocodone. E-pharmacies, even those with staff doctors who review online medical applications, can be alarmingly lax in prescribing and dispensing drugs. Teens, and even young kids, in search of a fix now have unprecedented access to addictive narcotics, mind-stimulating prescription uppers, and body-bulking anabolic steroids.Other investigators also received online drugs with relative ease. A locked metal safe at the New York City security firm Beau Dietl & Associates holds almost 100 packages of Internet-purchased drugs. In its investigation for a drug-trade group, the Pharmaceutical Research and Manufacturers of America, the Dietl firm received antibiotics, antidepressants, stimulants, cholesterol-lowering drugs, and weight loss medications. Three-quarters came from sites that didn't require a prescription.

"The Internet makes it possible for anybody to get any drug at any time. That's a scary thing," says Bill Livingstone, director of studies and analysis at GlobalOptions, a risk management consultancy that recently reported on the dangers of online pharmacies for the anticounterfeiting firm Reconnaissance International.

You can get ripped off.Our sources were. They paid $900 for three orders that were never delivered. Despite assurances from the customer service departments of the sites where they were purchased, the drugs were still missing 3 months later. On many sites, whatever savings are advertised can be eaten up by hefty "consultation" fees and inflated shipping costs--not to mention the fact that you risk identity and credit card theft, especially as criminals go into the online drug business.[pagebreak]

Buying Drugs Online Can Be Deadly

In 1999, Todd Rode, a 38-year-old Chicago man, died of an overdose after taking drugs he purchased online. Rode was already taking doctor-prescribed medication for his severe depression when he ordered a lethal combination of antidepressants and painkillers from a South African Internet site. The online pharmacy didn't require a prescription; it just took his Visa number. "These sites appeal to people who are very sick and very vulnerable," says Rode's mother, Helen. She and her husband, Edwin, have spoken out on the dangers of online pharmacies, even testifying before a 2001 congressional sub-committee. "We want to prevent this from happening ever again," she says.

Lab tests showed that Rode's Web-bought drugs contained the correct amount of active ingredients, but that's not always the case. Some sites hawk phony drugs that contain either trace amounts or no active ingredients. Sugar and starch are commonly used as fillers for fake drugs; some counterfeits contain boric acid, lead-based highway paint, and even cement, according to reports from US Customs and Border Protection and other agencies. In a recent case, an injectable medication was counterfeited with bacteria-tainted water.

However, it's not what's in the phony drugs but what isn't that's more likely to kill you. "For a guy, it's probably not catastrophic if the medication he's taking doesn't help him regrow his hair," points out John Gans, PharmD, executive vice president of the American Pharmacists Association. "But it might be the end of the world if his blood pressure medicine didn't work and he had a stroke."

In our investigation, Prevention asked ConsumerLab.com to analyze five batches of Viagra from apparent foreign and US sites to determine whether the drugs contained the active ingredient, sildenafil citrate. In all five cases, the amount fell into an acceptable range for US drug specifications. Separately, staffers at the Dietl firm bought the antibiotic Cipro online and sent it to a lab for evaluation. The drug, ordered from a seemingly American site but shipped from Pakistan, turned out to be only 65 percent potent.E-prescribing doctors miss red flags.Even the sites that require customers to fill out an online medical questionnaire make mistakes. On average, e-doctors evaluate 300 applications a day. That amounts to about 90 seconds per application if the physician works an 8-hour day with no break. Because they're paid from $5 to $80 per application, doctors have considerable incentive to rush through the pile. One particularly ambitious physician rubber-stamped 1,700 applications in a single day, reports the Federation of State Medical Boards. With this volume, it's easy for mistakes to slip through. On an online form, the 9-year-old son of a New York City investigator said truthfully that he was 4'8" and weighed 70 pounds--far below the size of most healthy adults--but he received Prozac anyway.

To their credit, several e-pharmacies did refuse to fill our sources' potentially dangerous orders. One turned down an application for Viagra after our source listed high blood pressure on the e-medical form. Another advised a 16-year-old who claimed to be 18 to "contact your pediatrician."[pagebreak]But other sites went out of their way to help customers who otherwise wouldn't have qualified get the drugs they wanted. When a Preventionsource listed a body weight that was too low to get a diet drug, one site supplied an on-screen weight and height calculator, which the source quickly used to reach a qualifying number. Some sites selling anti-impotence drugs had all the obviously "correct" answers to the medical questionnaire set as the default. In most cases, it took less than 10 minutes to place an order.

Our investigation showed that applicants are able to lie about everything--age, gender, weight, physical condition, doctor's name and phone number, even the patient's name--to get drugs. They never have to see or speak to another person, so there is no way for anyone to know they're lying.

Your Kids Have a Cyber Supplier

More than 2 million kids from 12 to 17 abuse prescription medications--and the Internet gives them easy access to the drugs they want. Viagra, a popular online seller, is half of a potentially deadly "club drug" combo that includes poppers, the street term for amyl nitrite. While a 16-year-old was denied Viagra on one site, a different US e-pharmacy shipped him the drug after he listed his age as 22 on its online form.

With just a few clicks, the 13-year-old daughter of private investigator Beau Dietl received Ritalin, which is prescribed for attention deficit hyperactivity disorder and is a common recreational drug among teens. She also got the potentially addictive weight loss drug Bontril.

Some sites and message boards actually coach teens through the process of ordering steroids, uppers, and sex-enhancement contraband. One steroid-hawking site even offers encrypted e-mail, which it promotes as so secure that "no one can read it, not even the FBI."Online drug dealing gives criminals and terrorists new options.Virtual pharmacies are so lucrative that drug cartels are getting into the action. "These guys make more money counterfeiting drugs than selling illegal street drugs," says Mark Werny, general manager of the anticounterfeiting consulting firm GenuNet. "There are higher profit margins and lesser penalties." Government and law enforcement officials worry that online pharmacies provide the perfect opportunity for terrorists to infiltrate our medical supply. The 2003 analysis by GlobalOptions reports:

"A terrorist organization, with limited technical skills, could set up an online pharmacy, generate a customer base, and then deliver tainted goods to unwitting consumers from virtually anywhere in the world....Each bottle of poison-tainted counterfeit drug can become a ticking time bomb."[pagebreak]

How to Avoid the Risks

Given the results of Prevention's investigation, it may come as a surprise that there is a safe way to order drugs from the Internet. Experts from the FDA, the American Medical Association (AMA), and pharmaceutical boards advise consumers to use only those sites that require a preliminary doctor's visit and a mailed or faxed prescription. "If a site offers a cyberspace consultation or medications without a prescription, stay away from it," cautions Carmen Catizone, executive director of the National Association of Boards of Pharmacy (NABP).

The NABP sanctions some sites, giving its seal of approval to e-pharmacies that are US-based, require a prescription from a physical exam, and meet vigorous licensing and inspection rules. Some non-NABP-approved e-pharmacies also legitimately distribute their drugs from licensed drugstores, but it's extremely difficult for a consumer to figure out which ones are trustworthy and which are not. Even professionals have been stumped: In a recent study, the Internet pharmacy rating service Pharmacy Checker.com reviewed 12 Web sites but was only able to verify that six filled orders through a licensed bricks-and-mortar pharmacy.

Although many legislators and consumer groups say it's safe to buy from licensed Canadian sites that require a doctor's prescription, the practice is controversial and often violates the Federal Food, Drug, and Cosmetic Act.

And there's an added hitch. Shoppers need to be aware of a deceptive tactic known as "hiding under the maple leaf": Web sites that advertise themselves as Canadian or prominently display the familiar maple leaf flag but are actually registered elsewhere.

In a GlobalOptions study of 45 e-pharmacies that either appeared Canadian or advertised as Canadian, five were registered in the US and three in Barbados, one was registered in Mexico, and five were of unknown origin.Another GlobalOptions study of 432 Internet sites that contained either "Canada" or "Canadian" and a reference to pharmaceuticals in the Web address found that more than half were located outside of Canada. The FDA has received consumer complaints about drugs ordered from supposedly Canadian Web sites, but that arrived with return addresses from overseas locations such as India.

It is legal to purchase drugs from all NABP-approved US sites and some "no prescription necessary" US sites that operate in states that have no specific law banning them. Since many state and medical board laws were written before the Internet was conceived, they simply don't address the legality of e-pharmacies or the issue of online medical consultations.

However, some states and boards are starting to crack down. Nevada, for example, recently adopted a law making all e-consultations illegal. In Florida, the state medical board just implemented a resolution mandating that all state doctors have a face-to-face examination with their patients.[pagebreak]

...And Why We Don't

If it's so easy to avoid potential health and legal risks by sticking to approved sites, why are so many prescription drug buyers taking their chances with unapproved e-pharmacies? It's simple: They're drawn by the rock-bottom prices and selection, and they're looking for privacy. So-called lifestyle or embarrassment drugs that treat skin, hair, weight, and sexual problems rank among the Net's top sellers. Case in point: Pennsylvania-based magazine editor Rob Sharpe's* days of disappointing sex abated after he discovered a European Web site selling the anti-impotence treatment Cialis before it was FDA approved.

Cheryl Snyder,* a 56-year-old Florida retiree, buys her drugs from Canadian e-pharmacies because it's cheaper. She uses the Internet to fill prescriptions she gets from her local doctor. At one Canadian site, Snyder pays just $1.69 per osteoporosis pill, compared with the $2.23 per pill she used to shell out at her local Walgreens.

Retirees such as Snyder, as well as the uninsured and those with low incomes, swear by the efficiency and cost savings of ordering online. In dozens of Internet message board postings examined by Prevention, buyers said they now have access to affordable medications that are essential to their quality of life.

For those with life-altering health problems, the Web is also a portal of hope that supplies experimental Alzheimer's medications and narcotics that ease chronic pain. Desperate families turn to the Web for non-FDA-approved drugs from abroad, such as memantine, an Alzheimer's drug tested and used only in Europe until it was approved by the FDA in October of 2003. Prior to its US approval, staffers at the Alzheimer's Disease Research Center at Washington University in St. Louis fielded 57 calls from consumers looking for information on memantine and how they could obtain it.A breakdown in the doctor-patient relationship fuels some Internet sales, especially when a patient feels a doctor is dismissing the severity of his pain. "I just got sick of dealing with doctors," says Steven Taylor,* a 28-year-old Savannah, GA, telecommunications technician who's battled severe neck pain and backaches for 3 years. He began spending $300 every 3 months for Lortab and Lorcet painkillers from his Internet supplier after he and his doctors disagreed on the best course of treatment for him. "They don't treat you seriously," he says. "All you are is a chart number to them."

When Janice Cypress's* doctor wanted to do medical tests before giving her birth control pills to control her long, heavy, and painful menstrual periods, the 46-year-old Juneau, AK, office administrator secretly bought them from a site in Thailand. And Barbara Stouffer, the migraine-plagued New Jersey mother, turned to the Net when she couldn't find a doctor who could help her adequately manage her headaches. "At first, I started with [online] pharmacies in the US, but they were limited in the variety of drugs they carried, so I switched to using pharmacies in other countries," she says. "When I wanted a particular migraine drug that had codeine, I looked to overseas pharmacies." Stouffer, who orders painkillers from Mexico and Sri Lanka, used trial and error to determine which pills work best for her.

She's aware of the risks she's taking. "It's a bit creepy getting drugs from the Internet," she acknowledges. "But when you are going crazy from a migraine that's lasted 3 days, you'll try anything."

Others risk their lives for lesser reasons: Men with high blood pressure or who are taking nitrate-based heart medications still skip the checkup to buy Viagra from a "no prescription needed" site, even though it could kill them. "There are men who say, 'If I'm going to die, I'm going to die in the saddle,'" one pharmacist told Prevention.[pagebreak]

Real Dangers from Fake Drugs

Perhaps one of the biggest risks online shoppers take when ordering from rogue e-pharmacies is that they won't get the drugs they've paid for but instead will receive a look-alike that contains little or no active ingredients.

In technical terms, a counterfeit drug is an unapproved pharmaceutical that looks similar to the standard product from a major manufacturer. It may have the active ingredient but be either too potent or not potent enough, or contain harmful substances. Genuine drugs that have been falsely relabeled to cover up past expiration dates or to claim higher amounts of the active ingredient are considered counterfeits too.

It's virtually impossible to determine the extent of the counterfeiting problem. One reason: Many counterfeits go unreported because consumers don't realize they're using a bogus medication. Even so, the number of counterfeiting cases investigated by the FDA has risen from 5 per year in the late 1990s to 22 in 2002. "There's a growing realization that the US market is very lucrative, and counterfeiters know that," says Tom Kubic, a former FBI agent who's now executive director of the Pharmaceutical Security Institute, which tracks fake drugs. "This is a market where they can make a lot of money."

The US pharmaceutical system is tough to infiltrate, and the risk of getting phony medication through a licensed US pharmacy remains relatively small. But in several apparently isolated incidents, counterfeiters were able to taint our drug supply with fake versions of the anemia drug Procrit (which was diluted with bacteria-filled tap water) as well as the cholesterol drug Lipitor and the AIDS treatment Serostim. At the time of the Serostim fakes, the FDA warned that "preliminary information appears to indicate that the counterfeit material may have been distributed via the Internet." According to news reports and the FDA, AIDS patients who took the fake Serostim experienced uncomfortable stinging and swelling at the injection site and excruciating body cramps.The FDA doesn't know how many consumers have experienced long-term health problems because of counterfeit drugs, but evidence from the agency and police raids shows that the number of fakes coming into the country--both to bricks-and-mortar and virtual pharmacies--is on the rise.

Many knockoffs are arriving from overseas, say pharmaceutical and counterfeiting experts. And online shoppers are inviting them in. In 2003, US consumers spent an estimated $1.4 billion ordering drugs from foreign Internet sites, including ones in Canada and Mexico. That's twice as much as they spent in 2002, reports Jupiter Research, a firm that analyzes Internet sales.

With the demand for drugs from abroad high and growing, foreign counterfeiters are perfecting their craft. Aaron Graham, a former agent at the Drug Enforcement Administration who's now in charge of global security for drugmaker Purdue Pharma, gave Preventiona glimpse into the shady world of counterfeiters. He showed us scores of evidence photos in which phony meds were displayed next to the real thing. They appeared identical. "You won't know they're counterfeit," says Graham. "Even the packaging is dead-on."

Although fake meds look sophisticated, many of the labs that produce them are anything but. When agents of US Immigration and Customs Enforcement (ICE) and the Thai Royal Police raided the back room of a run-down Thai house in 2000, they found batches of knockoff Viagra. Assisting this small-time counterfeiter: a prostitute with hepatitis. Separate ICE searches unearthed pills mixed with vodka to make the ingredients stick together. In their investigations, pharmaceutical manufacturers witness much of the same.

"There's stuff made in basements, garages, and warehouses that are filthy," says Jim Christian, global head of security for the pharmaceutical giant Novartis. Most counterfeiters want to get the active ingredient correct--it makes for repeat business. But in the unregulated and often unsanitary manufacturing conditions overseas, there's always the chance that the drug's calibrations are off. While the birth control pills Cypress ordered from Thailand worked, doctors worry that self-prescribing women may get more than they bargained for. "There are birth control pill dangers" such as stroke or blood clots, says John Nelson, MD, president-elect of the AMA. "And with a too light dose, you may find yourself pregnant."[pagebreak]

¿Habla Español?

Even if the drug you receive turns out to be the real thing, it may have been improperly stored and shipped. Or you may not know how to take it if the directions for use are supplied in a language you can't read--or if there are no instructions at all.

In September 2003, the FDA warned consumers that the Web site CanaRx.comshipped its drugs unsafely--including insulin, which should be stored under refrigeration. CanaRx vouches for the safety of its drugs and is working with the FDA to resolve the issue.

In Prevention's investigation, our sources received two punctured blister packs of Accutane and a batch of two different erectile dysfunction pills that rolled loose in plastic bags.

When Pennsylvania-based journalist John Klein* ordered anti-anxiety drugs online, the 30 tablets arrived in less than a week. Absent from the package were warnings of potential withdrawal problems such as dizziness, confusion, and sweating--precautions the manufacturer normally would include in an insert. In 2001, a joint FDA/US Customs study found that approximately 8 percent of 721 drug shipments contained no labeling at all or only foreign-language labeling.

"Package inserts and information vary from country to country," says Marv Shepherd, PhD, director of the Center for Pharmacoeconomic Studies at the University of Texas in Austin, "so even if you get a legitimate product, how do you know if you're taking it right? Is it three times a day with food? Without food? What are signs of an overdose or adverse reaction?"During our investigation, some of our sources received medications with no labels or labeled in a foreign language. Drugs that can cause birth defects or heart problems came with instructions solely in Spanish. None of the drugs from overseas listed the name or phone number of a doctor or pharmacy to follow up with in case of an adverse reaction.[pagebreak]

E-Pharmacies Defend Their Business

In 1999, 52-year-old Robert McCutcheon, a Lisle, IL, man reported to have had incidents of chest pain and a family history of heart problems, bypassed the doctor's exam and ordered Viagra online. After leaving a pub one evening, he took some pills, had sex with his girlfriend, and died of a heart attack. Although there is no direct proof Viagra caused his death, his case is often cited by critics of online drug-buying because McCutcheon did not have a prior face-to-face doctor visit.

When Prevention asked executives at e-pharmacies about their liability in cases like McCutcheon's, they were quick to blame the buyer. "Consumers are asked to attest to the fact that they're telling the truth," says a spokesperson for USAPrescription.com, adding that e-pharmacy shoppers are required to click on a mandatory legal disclaimer verifying their information. (USAPrescription had no involvement with McCutcheon's case.)

USAPrescription.com, which uses online questionnaires, is in the same position as the physician who sees patients in an office, says the spokesperson, who did not want to be named. "There's nothing stopping a guy from going to a doctor, lying, and saying he doesn't have a heart problem [and getting Viagra]. People who want to trick the system will do it."

But the AMA and the Federation of State Medical Boards (FSMB) disagree with this position: Without an in-person appointment with a physician, these groups say, the risk of misdiagnosis and of patients getting the wrong prescription or dose increases significantly.

In 2001, the Florida Department of Health charged a USAPrescription-fulfilling pharmacy, Rx Network, with 27 allegations of improper prescribing. After a formal hearing, an administrative law judge upheld only one charge and dismissed the rest. In Prevention's investigation, USAPrescription was one of the few e-pharmacies that denied orders for medical reasons: The site filled those that listed legitimate symptoms, but rejected the ones indicating red-flag health problems.USAPrescription wouldn't give us access to its prescribing physicians. However, Prevention contacted a doctor unaffiliated with the company. Miles Jones, MD, a Missouri-based advocate of e-prescribing, has written more than 35,000 Internet-based prescriptions. Jones is the medical director for Net Doctor International, owner-operator of NetDr.com, which, he says, has a "you lie, you could die" disclaimer warning people not to put down false answers on its medical questionnaire or risk potentially harmful or deadly complications. "Internet prescribing can be extremely safe if you're ethical and have guidelines," Jones maintained during a nearly 2-hour interview. An articulate, soft-spoken man, he asserts that NetDr.com shoppers actually get better medical care online than they do during some office visits. Customers have access to pharmaceutical news, drug warnings, and medical studies posted on the site, he says, adding that NetDr.com doesn't sell controlled or potentially addictive drugs.

NetDr.com does sell Viagra, which can have deadly side effects for some men. But Jones says that an unpredictable adverse reaction is a risk anyone takes when going on medication--whether he is diagnosed in a face-to-face doctor visit or by cyber evaluation. Jones contends that the consistency of an online questionnaire guarantees that the right questions are asked every time someone tries to get a prescription. And he emphasizes that e-prescribing eliminates some of the hassles that keep people from seeing their doctor in the first place--making appointments, sitting in waiting rooms, and having to fill prescriptions at their local pharmacy.

Though Jones presents himself as a patient-oriented pioneer of e-prescribing, others see him differently. Ten states have revoked his medical license, and three have suspended it for prescribing medications without a valid physician-patient relationship, according to the FSMB. He still legally practices in nine states.

Many regulators say that most e-prescribers aren't on the leading edge of a new, improved medical future--they're doing it for the money. "The typical Internet provider is a semiretired or retired physician" who wants to bolster his bank account, says an investigator who has tracked online pharmacies for 4 years but asked to remain anonymous. "If the medical board pulls their license, these doctors say, 'I don't care anyway.' They're not scared of sanctions."

Doctors who want to get into the Internet business respond to ads posted on Web sites and sometimes solicit e-pharmacies directly to become prescribing docs. "Doctors e-mail us" to determine work opportunities, says Jude LaCour, founder of Pillstore.com, which sets up online consultations that are sent to doctors who review them and then forward prescriptions to US pharmacies. LaCour agrees that doctors may be looking to make extra money but maintains that his site's prescribing doctors have high standards, turning down an average of 17 percent of orders based on medical concerns.

The allure of quick cash is also behind the rapid proliferation of e-pharmacies. FDA records show that one operator reaped more than $28 million in prescription drug sales, doctor consultation charges, and shipping fees. Neither of the two sites run by this operator had a licensed pharmacist on staff. And $28 million is at the lower end of the spectrum. "Some of these operations are big--to the tune of hundreds of millions of bucks," says Lew Kontnik, a security consultant who has worked closely with the FDA on anticounterfeiting efforts and coauthored Counterfeiting Exposed: Protecting Your Brand and Customers.[pagebreak]

War on Drugs

Even though it can be illegal for individual consumers to receive drugs shipped from foreign countries, a number of state and federal politicians as well as health advocacy groups have encouraged their constituents to order from Canadian sites in order to save money. And many people are doing it. It's rare for individual packages of prescription drugs to be stopped at the border by FDA and US Customs officials. Overworked and understaffed, these agencies don't have the manpower to police for illegal consumer prescriptions. They're grappling with terrorism concerns and illegal aliens, so Aunt Betsy's cholesterol drugs from Canada are low on the priority list.

"Largely due to the advent of Internet sites selling prescription drugs from all points around the globe, the volume of parcels containing prescription drugs has increased dramatically, beyond the ability of Customs and FDA staff to efficiently process," says William Hubbard, FDA associate commissioner for policy and planning. Of the millions of drug packages that arrive across US borders every year, only a small percentage are examined.

Instead of focusing on buyers, the FDA and other government agencies are clamping down on distributors. State medical boards are also penalizing doctors for overprescribing. In the past several months, state attorneys general have even filed lawsuits against shady drug vendors.

But some observers say the government isn't doing enough. "The FDA allows fly-by-night Internet con men to send whatever placebos, poisons, outdated drugs...through UPS, through FedEx, through other contract carriers," said Congressman John Dingell, a Democrat from Michigan, in 2003 congressional testimony. Four years ago, the FDA instituted an ongoing "cyber" letter campaign in which the agency sends out threatening e-mails to e-pharmacies that break US prescription drug laws--but it has been criticized for not being aggressive enough. The FDA contends that the campaign is working, saying that 30 percent of sites that receive a "cyber" letter close up shop. The agency is taking a harder line against illicit sites, and as of the fall of 2003 had 106 convictions related to Internet pharmacy cases.Not everyone is happy about the government's taking tougher action, however. There are politicians like Minnesota Congressman Gil Gutknecht and consumer groups such as AARP and the Vermont-based United Health Alliancethat want the FDA to back off and let Americans have access to inexpensive drugs. These proponents say the rewards outweigh the potential risks: It's better for senior citizens to take medications from a legitimate foreign distributor than not to get their meds at all. "The FDA's concerns for safety apparently do not extend to seniors who cannot afford their prescribed drugs," says Gutknecht. "The FDA does not look at the issue as if [these senior citizens] are sustaining their health. The FDA sees only that they are improperly importing pharmaceuticals."

The issue has become highly politicized. In July of 2003, with much fanfare, House legislators looking to save their constituents money signed off on a bill that sanctions drug imports from 25 foreign countries, including Canada, Japan, South Africa, and the European Union. These legislators say that with strict oversight by the FDA, foreign drugs can safely be imported into this country.

"For every other consumable good, Congress, the FDA, and the USDA have created standards and regulations to promote safety in importation," says Gutknecht, who sponsored the bill. "Through cooperative governmental efforts, we drink imported fruit juice and eat imported meats with confidence. We can accomplish the same for prescription drugs."

The FDA and pharmaceutical organizations disagree, saying that if we open our doors to foreign drug imports, it will threaten the safety of our national drug supply.[pagebreak]

Caveat Emptor

So what do you do? The low prices and convenience alone make buying drugs online tempting. But our investigation suggests that it's easy--almost inevitable--for the average consumer to stray into risky territory when buying from unapproved sites. You could get counterfeit or potentially dangerous medications. You could lose a substantial amount of money on drugs that are never delivered. Your kids could have easy access to a smorgasbord of recreational drugs and steroids.

As the e-pharmacy business grows, the government, major pharmaceutical companies, and even e-pharmacies themselves are moving to make Web drug shopping safer for everyone. The FDA is looking into anticounterfeiting track-and-trace technologies and harsher penalties for unscrupulous operators. Some e-pharmacies have created groups, such as the Council for Responsible Telemedicine and Health Internet Ethics, to set prescribing guidelines and police their own industry.

The big drug companies are hiring highly specialized security experts who formerly worked for the Drug Enforcement Administration and the Secret Service to ferret out illicit suppliers. Roche, for one, created an internal watch group that discovered 108 sites in the US and abroad that illegally offer its acne drug Accutane for sale. Roche is providing the FDA with the names of e-pharmacies that dispense Accutane and plans to send such sites warning letters.

In the end, though, the final gatekeeper is you. Already, an estimated 7,000 people die each year from medication-related errors, some of them made by medical personnel who have years of training and experience. If more and more consumers with no training and no experience begin self-prescribing from "no prescription needed" Web sites, that number could increase dramatically.The bottom line, experts say, is this: Consider your risks, then think twice about buying from suspect Web sites. "Some of the drugs you order are good products, some may not be," says the University of Texas's Shepherd. "It comes down to 'buyer beware.'"

Laura PetreccaLaura Petrecca, formerly a Prevention senior editor, is now a reporter for the USA Today.

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